 "Sun Pharma recalls anti-allergic drug in the US")
Sun Pharmaceuticals has initiated a recall of over million boxes of anti-allergic Loratadine drug from the US market after checks revealed the tablets were 'super potent' and 'out of specification'.
Loratadine tablets are manufactured and distributed in the US market by Ohm Laboratories, a New Jersey-based subsidiary of Ranbaxy. Sun Pharmaceuticals acquired Ranbaxy in a $4 billion deal in 2014 making it the largest Indian pharma company by sales.
While all the four plants of erstwhile Ranbaxy - Mohali and Toansa in Punjab, Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh - have US Food and Drugs Administration import alerts, now Ranbaxy's US facility too is under the scanner because of a drug recall. In all, Sun Pharma has eight manufacturing plants in the US.
Ohm Laboratories manufacturing facility is situated in New Jersey and it makes prescription and OTC drugs in solid form. The recalled drug Loratadine is a generic version of Bayer's Claritin.
US Food and Drugs Administration released the recall details in an enforcement report on its website. It said the recall was voluntary and initiated by the company itself and classified it as a Class III recall. A class III recall means that the use of or exposure to a violative product is not likely to cause adverse health consequences.
Such recalls are carried out by drug makers if there is a lacunae or defect in product and if left undaddressed can result in stricter action from regulators.
Sun Pharma did not comment on the recall initiated by Ohm Laboratories.
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In an analyst call earlier this year Sun Pharmaceuticals managing director Dilip Shanghvi said the company will work on one plant at a time to restore compliance at Ranbaxy's facilities. He had said it was important to establish trust between Ranbaxy and US FDA.
Due to compliance issues FDA had last year withdrawn the approval to Ranbaxy for 180 day exlcusivity to sell generic version of Astra Zeneca's heartburn drug Nexium and Roche's Valcyte anti viral drug post patent expiry.
US contributes to a half of Sun Pharma's revenue but its sales in the market have been impacted following US Food and Drug Administration imposed restrictions on production facilities in India. In the Q1 US sales were down 4 percent due to temporary supply constraints arising out of Halol plant, the company had said.